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Study 3 of 29 for search of: | Macedonia, The Former Yugoslav Republic of |
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Sponsored by: |
AtheroGenics |
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Information provided by: | AtheroGenics |
ClinicalTrials.gov Identifier: | NCT00525577 |
This double-blind, placebo-controlled, dose-finding study is designed to identify the lowest AGI-1067 dose that improves glycemic control as measured by HbA1c and fasting glucose in subjects with Type 2 diabetes mellitus. Glycemic control will be measured during a 6-month treatment period in subjects who are on 1 or no antidiabetic drugs
Condition | Intervention | Phase |
---|---|---|
Diabetes |
Drug: Placebo Drug: AGI-1067 |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | AGI-1067 as a Novel Antidiabetic Agent Evaluation Study |
Estimated Enrollment: | 1012 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1:A: Experimental
Placebo
|
Drug: Placebo
Placebo tablet, once daily
|
2:B: Experimental
AGI-1067 75 mg
|
Drug: AGI-1067
75 mg AGI-1067 tablet, once daily
|
3:C: Experimental
AGI-1067 150 mg
|
Drug: AGI-1067
150 mg AGI-1067 Tablet, once daily
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Walker Long, MD | AtheroGenics, Inc |
Responsible Party: | AtheroGenics, Inc ( Walker Long, MD ) |
Study ID Numbers: | AGI-1067-052 |
Study First Received: | September 4, 2007 |
Last Updated: | February 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00525577 |
Health Authority: | United States: Food and Drug Administration; South Africa: Medicines Control Council; India: Ministry of Health; Georgia: Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Ukraine: Ministry of Health; Macedonia: Ethics Committee; Russia: Pharmacological Committee, Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices |
Type 2 diabetes, glycemic control |
Diabetes Mellitus, Type 2 Diabetes Mellitus |